Swedish, Rapid Infuser RI-2, 230V, 1000 ml/min 903-00037A-SWRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00896128002794), received between Mar 21, 2019 and Jan 8, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 8, 2021No Apparent Adverse Event; No Apparent Adverse Event

  BELMONT'S DISTRIBUTOR REPORTED THAT A BELMONT RAPID INFUSER, RI-2 WAS EXHIBITING INTERMITTENT SYSTEM ERROR #215 ALARMS DURING USE. THE TIME AND DATE WERE NOT DISPLAYING PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11142782 ↗
• MalfunctionMar 21, 2019Infusion or Flow Problem; Appropriate Device Problem Term/Code Not Available; Infusion or Flow Problem; Appropriate Device Problem Term/Code Not Available

  OUR DISTRIBUTOR RECEIVED A COMPLAINT FROM THE USER AND RELAYED THE FOLLOWING REPORT: "IT STARTED TO CLOG IN THE SMALL RESERVOIR AND ALSO IN THE PATIENT LINE. THE SYSTEM WAS FLUSHED WITH BOLUS INFUSION DURING THE PROCEDURE, THE DISPOSABLE WAS CHANGED DUE TO THE CLOG AND THE PROCEDURE COULD PROCEED WITHOUT PROBLEMS. THE CLINIC HAS NOT PROVIDED THE RESERVOIR LOT NUMBER AND HASN'T SAVED THE DISPOSABLE SET (THROWN AWAY). PICTURES." OUR DISTRIBUTOR THEN FOLLOWED UP WITH THE FOLLOWING INFORMATION: "THE SYSTEM WAS USED UNDER AN OPERATION FOR SPINAL STENOSIS WITH AN ESTIMATED TIME OF ALMOST 10 HOURS. THE PROBLEM OCCURRED AFTER A TOTAL OF 8 HOURS OF INFUSION. AND THE SYSTEM HAD BEEN USED FOR TRANSFUSION OF BOTH PRBC AND FFP NO RINGER LACTATE/ACETATE WAS INFUSED THROUGH THE SYSTEM. AFTER THE CLOT WAS DETECTED (THE SYSTEM ALARMED FOR HIGH PRESSURE) THEY CHANGED THE DISPOSABLE AND CONTINUED THE PROCEDURE WITHOUT PROBLEM. THE PATIENT WAS NOT INJURED. UNFORTUNATELY, THEY HAVEN'T SAVED THE LOT ON THE DISPOSABLE AND HAS THROWN IT IN THE GARBAGE. (THEY SAW IT AS A PROBLEM WITH SLOW INFUSION OR NO INFUSION DURING A LONG PROCEDURE)."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8441928 ↗